The MDR Guidebook
An essential tool for any device manufacturer selling into Europe
With the EU Medical Device Regulation (MDR) looming and requiring implementation by 2020, we have created a guidebook and training course to help you get prepared.
For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.
It contains a number of useful tools and tables to guide you through the MDR, such as:
device classification and their differences from the MDD
QMS requirements and how they align with ISO 13485
technical documentation requirements
clinical data requirements, including a handy checklist
general safety and performance requirements tables
annex and article guide
£225 (exc VAT & Shipping)
Ebook available now
RAPS has teamed up with us to offer our MDR Guidebook in a convenient e-book format.
*Note: Internet access is required to read all RAPS e-books. E-books cannot be downloaded for offline use.